`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MEDTRONIC, INC. and MEDTRONIC VASCULAR, INC.,
`Petitioners,
`
`v.
`
`TELEFLEX LIFE SCIENCES LIMITED,
`Patent Owner
`
`IPR2020-01342
`Patent 8,142,413 B2
`
`PETITIONERS MEDTRONIC, INC. AND MEDTRONIC VASCULAR,
`INC.’S NOTICE OF APPEAL UNDER 37 C.F.R. § 90.2(a)
`
`
`
`
`
`
`
`
`
`
`Pursuant to 35 U.S.C. §§ 141-144, 319, and 37 C.F.R.§ 90.2(a), notice is
`
`hereby given that Petitioners Medtronic, Inc. and Medtronic Vascular, Inc.
`
`(“Medtronic”) appeal to the United States Court of Appeals for the Federal Circuit
`
`from the Final Written Decision (“Final Written Decision”) (Paper No. 74, dated
`
`February 7, 2022) entered by the United States Patent and Trademark Office,
`
`Patent Trial and Appeal Board (“Board”) in IPR2020-01342, and from all
`
`underlying orders, decisions, rulings, and opinions. A copy of the Final Written
`
`Decision is attached hereto as Exhibit A.
`
`In accordance with 37 C.F.R. § 90.2(a)(3)(ii), Medtronic further indicates
`
`that the issues on appeal may include, but are not limited to, whether the Board
`
`erred in determining that claims 1, 2, 4, 5, and 7-14 of U.S. Patent Number
`
`8,142,413 were not shown to be unpatentable under 35 U.S.C. § 103, any findings
`
`supporting or related to the Board’s determination, and all other issues decided
`
`adversely to Medtronic in any order, decision, ruling, and/or opinion, including but
`
`not limited to the Board’s failure to properly consider evidence of record, the
`
`Board’s legal errors in undertaking the obviousness analysis, and the Board’s
`
`findings that conflict with the evidence of record and are not supported by
`
`substantial evidence.
`
`Simultaneous with this submission, a copy of this Notice of Appeal is being
`
`filed through the Patent Trial and Appeal Board End to End (“PTAB E2E”)
`
`1
`
`
`
`System. In addition, a copy of the Notice of Appeal, along with the required
`
`docketing fee, is being filed with the Clerk of Court for the United States Court of
`
`Appeals for the Federal Circuit.
`
`
`
`Dated: April 6, 2022
`
`Respectfully submitted,
`
`
`
`
`
`
`
`
`
`
`
`
`/s/ Cyrus A. Morton
`Cyrus A. Morton
`ROBINS KAPLAN LLP
`800 LaSalle Avenue, Suite 2800
`Minneapolis, MN 55402
`(612) 349-8500
`Attorney for Petitioners
`
`
`
`2
`
`
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that on this April 6, 2022, a copy of Petitioners Medtronic,
`
`Inc. and Medtronic Vascular, Inc.’s Notice of Appeal Under 37 C.F.R. § 90.2(a)
`
`was served in its entirety by electronic mail on Patent Owner’s counsel at the
`
`following addresses included in Patent Owner’s Mandatory Notices:
`
`J. Derek Vandenburgh, Reg. No. 32,179
`dvandenburgh@carlsoncaspers.com
`
`Dennis C. Bremer, Reg. No. 40,528
`dbremer@carlsoncaspers.com
`
`Joseph W. Winkels
`jwinkels@carlsoncaspers.com
`
`Peter M. Kohlhepp
`pkohlhepp@carlsoncaspers.com
`
`Tara C. Norgard
`tnorgard@carlsoncaspers.com
`
`Megan E. Christner, Reg. No. 78,979
`mchristner@carlsoncaspers.com
`
`Shelleaha L. Jonas
`sjonas@carlsoncaspers.com
`
`
`Dated: April 6, 2022
`
`
`
`
`
`Respectfully submitted,
`/s/ Cyrus A. Morton
`Cyrus A. Morton
`Reg. No. 44,954
`Attorney for Petitioners
`
`
`
`3
`
`
`
`
`
`
`Exhibit A
`Exhibit A
`
`
`
`ÿ
`ÿ
`ÿ
`ÿ
`
`MEDTRONIC, INC., AND MEDTRONIC VASCULAR,INC.,
`Petitioner,
`
`V.
`
`TELEFLEX LIFE SCIENCES LIMITED,
`Patent Owner.
`
`IPR2020-01342
`Patent 8,142,413 B2
`
`
`Before SHERIDAN K. SNEDDEN, JAMES A. TARTAL,and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`SNEDDEN,Administrative Patent Judge.
`
`Trials@uspto.gov
`571-272-7822
`
`Paper No. 74
`Date: February 7, 2022
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
` ÿ
`ÿÿ
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`JUDGMENT
`Final Written Decision
`Determining No Challenged Claims Unpatentable
`35 U.S.C. § 318(a)
`
`
`
`IPR2020-01342
`Patent 8,142,413 B2
`
`I.
`
`INTRODUCTION
`
`Wehavejurisdiction under 35 U.S.C. § 6. We issue this Final Written
`
`Decision pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73 in an inter
`
`partes review involving Medtronic,Inc., and Medtronic Vascular,Inc.
`
`(“Petitioner”) and Teleflex Life Sciences Limited (“Patent Owner”).' Based
`
`on the record before us, we concludethat Petitioner has not demonstrated,
`
`by a preponderance ofthe evidence, that claims 1, 2, 4, 5, and 7-14 of U.S.
`
`Patent No. 8,142,413 B2 (“the ’413 patent,” Ex. 1401) are unpatentable.
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`' Teleflex Life Sciences Limited (“Teleflex”) filed a notice identifying itself
`as the owner of U.S. Patent No. 8,142,413 B2. Paper 5, 2. Teleflex further
`explained, “Teleflex Innovations S.A.R.L. merged into Teleflex Medical
`Devices S.A.R.L., and Teleflex Medical Devices S.A.R.L. transferred
`ownership of U.S. Patent No. 8,142,413 to Teleflex Life Sciences Limited.”
`See id. at 2 n.1 (furthering stating that “[t]he assignment documents were
`recorded with the United States Patent & Trademark Office on January 27,
`2020”).
`? Redacted versions of the PO Response and Replyare entered as Papers 25
`and 41, respectively.
`
`A. Background
`
`Petitioner filed a Petition for inter partes review ofclaims 1, 2, 4, 5,
`
`and 7—14 of the ’413 patent. Paper 1 (“Pet.”). Patent Ownerfiled a
`
`Preliminary Response. Paper 7. We determined, based on the information
`
`presented in the Petition and Preliminary Response, that there was a
`
`reasonable likelihood that Petitioner would prevail in showingthatat least
`
`one of the challenged claims was unpatentable over the cited art. Pursuant
`
`to 35 U.S.C. § 314, the Board instituted trial on February 9, 2021. Paper 9.
`
`Following institution, Patent Ownerfiled a Responseto the Petition
`
`(Paper 24, “PO Resp.”), Petitioner filed a Reply to Patent Owner’s Response
`
`(Paper 40, “Reply”), and Patent Ownerfiled a Sur-reply (Paper 52).”
`
`
`
`IPR2020-01342
`Patent 8,142,413 B2
`
`On November 18, 2021, the parties presented argumentsat an oral
`
`hearing. The transcript of the hearing has been entered into the record.
`
`Paper 73.
`
`B. Related Matters
`
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`
`IPR2020-00131 and IPR2020-00133. Final written decisions are pending in
`
`Petitioner filed a separate Petition for inter partes review ofclaims 1,
`
`2, 4, 5, and 7—14 ofthe ’413 patent as IPR2020-01341. The final written
`
`decision is pending in IPR2020-01341.
`
`Petitioner also previously filed petitions challenging patents related to
`
`the ’413 patent in the following proceedings: IPR2020-00126 and IPR2020-
`
`00127 (Patent 8,048,032 B2); IPR2020-00128, IPR2020-00129, IPR2020-
`
`00130, and IPR2020-00131 (Patent RE45,380 E); IPR2020-00132,
`
`IPR2020-00133, and IPR2020-00134 (Patent RE45,760 E); IPR2020-00135
`
`and IPR2020-00136 (Patent RE45,776 E); IPR2020-00137 and IPR2020-
`
`00138 (Patent RE47,379 E); and IPR2021-01343 and IPR2021-01344
`
`(Patent RE46,116 E). Institution of inter partes review was denied in
`
`IPR2021-01343 and IPR2021-01344. Weissued final written decisions
`
`determining that none of the challenged claims were unpatentable in the
`
`other proceedings.
`
`The parties indicate that the ’413 patent is the subject oflitigation in
`
`Vascular Solutions LLC, et al. v. Medtronic, Inc., et al., No. 19-cv-01760
`
`(D. Minn.filed July 2, 2019) and OXMedical, LLC v. Vascular Solutions,
`
`LLC, No. 17-cv-01969 (D. Minn.filed June 8, 2017). Pet. 4—5; Paper 5, 2.
`
`
`
`IPR2020-01342
`Patent 8,142,413 B2
`
`C. The ’413 Patent
`
`1. Specification
`
`The ’413 patent, titled “Coaxial Guide Catheter for Interventional
`
`Cardiology Procedures,” issued on March 27, 2012, from a non-provisional
`
`application filed June 28, 2010. Ex. 1001, codes (45), (54), (22). The ’413
`
`patent relates generally to a coaxial guide catheter for use with interventional
`
`cardiology devicesthat are insertable into a branch artery that branchesoff
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`A guide catheteris typically seated into the opening or ostium of
`the artery to be treated and a guidewire or other instrumentis
`passed through the lumen of the guide catheter and inserted into
`the artery beyond the occlusion or stenosis. Crossing tough
`lesions can create enough backward force to dislodge the guide
`catheter from the ostium of the artery being treated. This can
`makeit difficult or impossible for the interventional cardiologist
`to treat certain forms of coronary artery disease.
`
`from a main artery. Ex. 1001, Abstract.
`
`Accordingto the ’413 patent, interventional cardiology procedures
`
`often include inserting guidewires or other instruments through catheters
`
`into coronary arteries that branch off from the aorta. Jd. at 1:21-23.
`
`In coronary artery disease, atherosclerotic plaques or other lesions may
`
`narrow or occlude the coronary arteries. Jd. at 1:26-30. The ’413 patent
`
`states that “[n]arrowing is referred to as stenosis.” Jd. at 1:30-31.
`
`“In treating a stenosis, a guide catheteris typically inserted through the aorta
`
`and into the ostium of the coronary artery,” sometimes with the aid ofa
`
`guidewire. /d. at 1:35-37. The ’413 patent further states as follows:
`
`Id. at 1:37-45. The ’413 patent discusses “four categories” of “[p]rior
`
`attempts to provide support to the guiding catheter to prevent backward
`
`dislodgement from the coronary ostium (referred to as ‘backup support’),”
`
`consisting of: (1) “guiding catheters that, through a combination of shape
`
`
`
`IPR2020-01342
`Patent 8,142,413 B2
`
`and stiffness, are configured to draw backup support from engaging the wall
`
`of the aortic arch;” (2) “guiding catheters that include a retractable
`
`appendage;”(3) guide catheters that have apportion that seeks to expand
`
`laterally;” and, (4) “placement of a smaller guide catheter within a larger
`
`guide catheter in order to provide add support.” Jd. at 1:46-2:39. The
`
`’413 patent identifies various deficiencies with these prior attempts,
`
`including an increased risk of damageto the aortic wall and mechanical
`
`complexity. See id. Specifically, with regard to the fourth category of prior
`
`attempts, the ’413 patent states as follows:
`
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`This technique is used in order to provide a method of deep
`seating the guide catheter within the ostium of the coronary
`artery. Deep seating refers to inserting the catheter more deeply
`into the ostium of the coronary artery than typically has been
`done before. Unfortunately, deep seating by this technique with
`a commonly available guide catheter creates the risk that the
`relatively stiff, fixed curve, guide catheter will damage the
`coronary artery. This damage may lead to dissection of the
`coronary artery when the catheter is advanced past the ostium.
`Several other problems arise when using a standard guide
`catheter in this catheter-in-a-catheter fashion. First, the inner
`catheters must be substantially longer than the one hundred
`centimeter guide catheter. Second, a new hemostasis valve must
`be placed on the inner guide catheter which prevents the larger
`guide catheter from being used for contrast injections or pressure
`measurements. Third, the smaller guide catheter still must be
`inserted into the coronary vessel with great care since the smaller
`guide catheter has no tapered transition or dilator at its tip and
`does not run overa standard 0.014 inch guidewire.
`
`Id. at 2:30-50. The ’413 patent states “a system that would be deliverable
`
`through standard guide catheters for providing backup support by providing
`
`the ability to effectively create deep seating in the ostium of the coronary
`
`artery” would be beneficial to “the interventional cardiologyart.” Jd.
`
`at 2:51-55.
`
`
`
`IPR2020-01342
`Patent 8,142,413 B2
`
`The ’413 patent describes “a coaxial guide catheter that is deliverable
`
`through standard catheters by utilizing a guidewire rail segment to permit
`
`delivery without blocking use of the guide catheter.” Jd. at 2:59-62. “The
`
`coaxial guide catheter preferably includes a tapered inner catheter that runs
`
`over a standard 0.014 inch coronary guidewire to allow atraumatic
`
`placement within the coronary artery,” allowing “removal of the tapered
`
`inner catheter after the coaxial guide catheter is in place.” Jd. at 2:62-67.
`
`Figures 1 and 2, reproduced below, show a coaxial guide catheter and a
`
`tapered inner catheter as described in the ’413 patent:
`
`Fig. 1
`10
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`Fig. 2
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`Figure 1 depicts tapered inner catheter 14 separate and above coaxial guide
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`catheter 12, and Figure 2 depicts coaxial guide catheter 12 and tapered inner
`
`catheter 14 assembled as coaxial guide catheter assembly 10. /d. at 5:22—27,
`
`6:12—14; Figs. 1 and 2. Coaxial guide catheter 12 includestip portion 16,
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`reinforced portion 18, and rigid portion 20. Jd. at 6:15—16. Tip portion 16
`
`generally includes bumptip 22 and marker band 24. /d. at 6:20—-21. Bump
`
`tip 22 includes taper 26 andis relatively flexible. Jd. at 6:21. Marker
`
`band 24 is formed of a radiopaque material such as platinum/iridium alloy.
`
`Id. at 6:25—26. Tapered inner catheter tip 42 includes tapered portion 46 at a
`
`distal end thereof, and straight portion 48. /d. at 6:65—66. Both tapered
`
`6
`
`
`
`IPR2020-01342
`Patent 8,142,413 B2
`
`portion 46 andstraight portion 48 are pierced by lumen 50 (not labeled in
`
`figures above). Jd. at 6:65-67. Tapered inner catheter 14 mayalso include
`
`clip 54 at a proximal end thereofto releasably join tapered inner catheter 14
`
`to coaxial guide catheter 12. Jd. at 7:3-S.
`
`Figures 8 and 9 of the ’413 patent are reproduced below.
`
`Fig. 8
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`In operation, a guide catheter 56 is inserted into a major blood
`vessel in the body such as aortic arch 58 over guidewire 64 and
`
`Figures 8 and 9 are schematic illustrations of guide catheter 56 with coaxial
`
`guide catheter 12 inserted into ostium 60 of coronary artery 62. Jd. at 5:43-
`
`49, 7:53-55, 7:67-8:4. The catheter assembly of Figure 8 includes optional
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`tapered inner catheter 14, whereas the apparatus of Figure 9 does not. Jd.
`
`The *413 patent states “the presence of coaxial guide catheter 12
`
`within guide catheter 56” provides “improved distal anchoring of guide
`
`catheter 56 and coaxial guide catheter 56” and “stiffer back up support than
`
`guide catheter 56 alone.” Jd. at 7:67-8:6. The ’413 patent describes in
`
`detail a methodofuse, as follows:
`
`
`
`IPR2020-01342
`Patent 8,142,413 B2
`
`Id. at 9:51-10:15; see also id. at 1:23—26 (stating that “the term
`
`the distal end 68 of guide catheter 56 is brought into proximity
`of ostium 60 of a smaller branch blood vessel, such as coronary
`artery 62, that it is desired to enter. Coaxial guide catheter 12,
`with tapered inner catheter 14,
`is
`inserted through guide
`catheter56 and over guidewire 64. Guide
`catheter 56,
`guidewire 64, coaxial guide catheter 12, and tapered inner
`catheter 14 are manipulated to insert tapered innercathetertip 42
`into the ostium 60 of the blood vessel that branchesoff from the
`major blood vessel. The bumptip 22 of coaxial guide catheter 12
`is inserted with tapered innercatheter tip 42 well into ostium 60
`of coronary artery 62 or other blood vessel until bump tip 22 of
`coaxial guide catheter 12 achieves a deep seated position.
`Tapered inner catheter 14 is then withdrawn from the lumen of
`coaxial guide catheter 12.
`An interventional cardiology
`treatment device such as a catheter bearing a stent or a balloon
`(not shown)is then inserted through the lumen of coaxial guide
`catheter 12 which remainsinside guide catheter 56.
`Whenthe interventional cardiology device reachesa steno sis
`or blockage in coronary artery 62 or another branch blood vessel,
`force may be applied to the interventional cardiology device
`catheter while reinforced portion 18 and rigid portion 20 of
`coaxial guide catheter 12 provide back up support. The back
`force that would tend to dislodge bumptip 22 from a deep seated
`position in the ostium in the branch blood vessel is transferred
`through reinforced portion 18 to rigid portion 20 of coaxial guide
`catheter 12. A physician may apply a force to the proximal end
`of the coaxial guide catheter 12 to resist dislodging of bump
`tip 22 from the ostium ofthe branchartery.
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`‘interventional cardiology devices’ is to be understood to include but not be
`
`limited to guidewires, balloon catheters, stents and stent catheters”). Patent
`
`Owner summarizes the method described in the ’413 patent and notes the
`
`use of the tapered inner catheter is optional. See PO Resp. 3 (stating that
`
`“To|ptionally, a tapered inner catheter may be inserted with the coaxial guide
`
`catheter and advancedto the second vessel, and removed before an
`
`
`
`(citing Ex. 1001, 9:55-66).
`
`2. Illustrative Claims
`
`Independent claim 1, reproduced below,is illustrative of the
`
`challenged claims.
`
`[1a] inserting the standard guide catheterinto a first artery
`over a guidewire, the standard guide catheter havinga distal end;
`
`[1b] positioning the distal end of the standard guide
`catheter in a branch artery that branchesoff from thefirst artery;
`
`[1c] inserting a flexible tip portion of a coaxial guide
`catheter defining a tubular structure having a circular cross-
`section and a length that is shorter than the predefined length of
`the continuous lumen of the standard guide catheter, into the
`continuous lumen of the standard guide catheter, and,
`
`[1d] further inserting a substantially rigid portion that is
`proximal of, operably connected to, and more rigid along a
`longitudinal axis than the flexible tip portion, into the continuous
`lumen of the standard guide catheter,
`the substantially rigid
`portion defining a rail structure without a lumen and having a
`maximal cross-sectional dimension at a proximal portion that is
`smaller than the cross-sectional outer diameterofthe flexible tip
`portion and having a length that, when combinedwith the length
`of the flexible distal tip portion, defines a total length of the
`
`IPR2020-01342
`Patent 8,142,413 B2
`
`[interventional cardiology device] is inserted into the coaxial guide catheter”
`
`[lpre.] A method of providing backup support for an
`1.
`interventional cardiology device for use in the coronary
`vasculature, the interventional cardiology device being adapted
`to be passed through a standard guide catheter, the standard guide
`catheter having a continuous lumen extending for a predefined
`length from a proximal end at a hemostatic valve to a distal end
`adapted to be placed in a branch artery, the continuous lumen of
`the guide catheter having a circular cross-sectional
`inner
`diameter sized such that interventional cardiology devices are
`insertable into and through the lumen, the method comprising:
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